BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 728242 · Received June 22, 2006

    Report

    Report Number
    2210968-2006-00438
    Event Type
    Injury
    Date Received
    June 22, 2006
    Date of Event
    January 1, 2006
    Report Date
    May 23, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    H6: CONCLUSION: EXPOSURE TO MESH CAN OCCUR FOR A VARIETY OF REASONS SUCH AS INADEQUATE MUCOSAL CLOSURE, ATROPHIC VAGINAL SKIN, OR POSTOPERATIVE TRAUMA TO NAME A FEW. THESE SOMETIMES CLOSE SPONTANEOUSLY WITH TIME AND ESTROGEN THERAPY; OTEHRS REQUIRE RESECTION IN THE OFFICE OF THE OPERATING ROOM. EXPOSURE IS A RISK WITH USE OF ANY FOREIGN MATERIAL. (510(K)#K013718)

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A PELVIC FLOOR REPAIR IN 2006. POSTOPERATIVELY, THE PATIENT EXPERIENCED A "TINY" AND "ASYPYOMATIC" VAGINAL OROSION WITH THE MESH, WHICH WAS NOTED WHEN THE PATIENT RETURNED TO THE DOCTOR FOR A FOLLOW UP VISIT SIX WEEKS LATER. THE PATIENT WILL RETURN TO THE SEE THE SURGEON IF SYMPTOMS OF DISCHARGE OR BLEEDING ARE NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL POLYMERIC FTL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization